Phase 3 Completed N=1,002 Randomized Triple-blind Treatment

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00567996 ↗

Enrolled (actual)

1,002

Serious AEs

7.4%

Results posted

Aug 2011

Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment — 1.45; 1.39; 1.28 Liters

Summary

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment	1.45; 1.39; 1.28	—
SECONDARY St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment	36.4; 38.5; 42.6	—
SECONDARY Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment	34.1; 34.1; 38.1	—

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

Smoking history of at least 20 pack years
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) or= 30% of predicted normal value
Post-bronchodilator FEV1/FVC 15h/day)
Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
Concomitant pulmonary disease
Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
History of reactions to sympathomimetic amines or inhaled medication
Inability to use the dry powder devices or perform spirometry
Irregular day/night, wake/sleep cycles, e.g. shift workers
Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00567996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.